OncoMatch/Clinical Trials/NCT06015503
A Phase Ⅱ Study Assessing the Safety and Efficacy of PLB1004 in EGFR ex20ins Mutation Patients With Advanced and Metastatic Non-small Cell Lung Cancer(NSCLC)
Is NCT06015503 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies PLB1004 for non-small-cell lung cancer.
Treatment: PLB1004 — It is a phase Ⅱ,open-label, single-line, Multiple cohorts, Multicenter study assessing the Safety and Efficacy of PLB1004 in EGFR ex20ins mutation patients with Advanced and Metastatic Non-small Cell Lung Cancer(NSCLC).
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR ex20ins mutation
Participants with EGFR ex20ins mutation.
Disease stage
Required: Stage IIIB, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: platinum-based chemotherapy — advanced disease
platinum containing ... systemic therapy
Must have received: immunotherapy — advanced disease
immunotherapy containing systemic therapy
Cannot have received: monoclonal antibody targeting EGFR
Any monoclonal antibodies targeting EGFR/HER2/VEGFR within 4 weeks
Cannot have received: monoclonal antibody targeting HER2
Any monoclonal antibodies targeting EGFR/HER2/VEGFR within 4 weeks
Cannot have received: monoclonal antibody targeting VEGFR
Any monoclonal antibodies targeting EGFR/HER2/VEGFR within 4 weeks
Cannot have received: cytotoxic chemotherapy
Any cytotoxic drugs or other anticancer drugs from a previous treatment regimen within 14 days
Cannot have received: anticancer herbal medicine
Any anticancer herbal medicine within 7 days
Cannot have received: anti-EGFR TKI
Exception: for the EGFR ex20ins mutation
Any anti-EGFR TKI for the EGFR ex20ins mutation
Cannot have received: third-generation anti-EGFR TKI
Exception: during the treatment having achieved a best overall response of the partial response or complete response
Any third-generation anti-EGFR TKI during the treatment having achieved a best overall response of the partial response or complete response
Lab requirements
Blood counts
Participants must have specific organ and bone marrow function.
Kidney function
Participants must have specific organ and bone marrow function.
Liver function
Participants must have specific organ and bone marrow function.
Participants must have specific organ and bone marrow function.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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